• How To Prepare A Facility For The Biopharmaceutical Revolution
    How To Prepare A Facility For The Biopharmaceutical Revolution

    Drug discovery is an inherently inefficient process. It takes thousands of failed compounds before one can get approved as safe and efficacious, and this effort does not come at a low cost. Because of this, the industry is constantly looking for ways to bring safe, compliant, and profitable drugs to market faster and cheaper. Patheon facility in Brisbane, Australia, exemplifies the facility needed to survive the future of pharma. But how did they do it?

  • Pharmaceutical Customers In An Outsourcing Provider Merger -- Part 3 Of Interview With CEO of Newly Formed DPx Holdings B.V.

    This final article in our series featuring Jim Mullen, CEO of newly formed DPx Holdings B. V., discusses how to keep the focus on customers during M&A activity, and the broader transformation of sponsor–provider relationships in the pharmaceutical outsourcing industry.

    Earlier articles from our interview with Mullen dealt with how an acquisition comes together, and the importance of understanding the relationship between quality, capacity and job security for the early success of any M&A deal. In some ways, we’ve left the most important subject – customers – for last.

  • Quality, Capacity And Job Security In A CMO Industry Merger -- Part 2 Of Our Interview With CEO Of Newly Formed DPx Holdings B.V.

    This spring Jim Mullen became CEO of DPx Holdings B.V., formed in a $2.65 billion transaction combining JLL Partners’ assets Patheon and Banner Life Sciences, with Royal DSM’s Pharmaceuticals business. In an interview with Outsourced Pharma, Mullen discusses three key components in a merger: quality, capacity and job security.

    With a merger nearing completion and the integration plans underway, Mullen says you have to start with the fundamental ABCs of business. “There are three fundamental questions to get to day one: Do you have the right financial controls? Can you reliably continue to pay your suppliers? Can you receive cash and can you make payroll?

  • Results of First Ever REMOTE Clinical Trial

    In the clinical research industry, we’re always evaluating things.  We evaluate drugs and biologics.  We evaluate medical devices.  We also evaluate research techniques.  Yes, we try trials.  We study studies.  That’s what Pfizer was doing when it launched its REMOTE pilot trial in early 2011 – evaluating the effectiveness of a study in which patients participated remotely, without ever having to visit a study site.  How would the results of the REMOTE study compare with those of a similar, completed, conventional study?  Would this innovative research approach be validated? By Laurie MeehanPolaris Compliance Consultants, Inc.

  • IMP Shipments: Too Big, Too Costly, Too Bad

    A client in the UK was initiating a new clinical trial, and shipping forty-two pallets of the IMP to Marken’s pharmaceutical service depot in the testing region created several challenges.

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